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ID

12902

Descrizione

Long-term Safety and Efficacy of Galantamine in Alzheimer's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00304629

collegamento

https://clinicaltrials.gov/show/NCT00304629

Keywords

  1. 05/01/16 05/01/16 -
Caricato su

5 gennaio 2016

DOI

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Licenza

Creative Commons BY 4.0

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    Eligibility Alzheimer Disease NCT00304629

    Eligibility Alzheimer Disease NCT00304629

    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    patients must have taken trial medication during the 24-month trial period of gal-int-8 and should be enrolled within 1 month after completion
    Descrizione

    medication

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    patients and their primary caregiver give informed consent for the participation in the trial
    Descrizione

    informed consent

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    patients must have remained in good health, as determined by medical history, complete physical examination and laboratory tests
    Descrizione

    health status

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0018759 (Health Status)
    SNOMED
    406221003
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    if a patient developed, during the trial gal-int-8, symptoms of other neurological or psychiatric diseases that might contribute to dementia, the subject cannot be enrolled. this includes subjects developing neurodegenerative disorders such as parkinson's disease, pick's disease or huntington's chorea, or creutzfeldt-jacob disease, and subjects with cognitive impairment resulting from stroke, acute cerebral trauma, hypoxic cerebral damage, infection or primary or metastatic cerebral neoplasia
    Descrizione

    dementia

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0497327 (Dementia)
    SNOMED
    52448006
    LOINC
    LA20372-1
    subjects with the following co-existing medical conditions: a) any history of epilepsy or convulsions except for febrile convulsions during childhood b) peptic ulcer: if the ulcer is considered to be still "active", i.e., if treatment for this condition started <3 months ago or if treatment is not successful (symptoms still present), the subject is not eligible. c) clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances
    Descrizione

    comorbidity

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0009488 (Comorbidity)
    patients with current, clinically significant cardiovascular disease that would be expected to limit the subject's ability to complete a 12-month trial. the following would usually be considered clinically significant cardiovascular disease: a) unstable angina
    Descrizione

    comorbidity

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [1,2]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    UMLS CUI [1,3]
    C0009488 (Comorbidity)
    angina or coronary artery disease that required a change in medication (anti-angina or digitalis) within the last 3 months b) decompensated congestive heart failure i.e. when symptoms occur in a subject on stable medication during rest or light exercise (nyha iii and iv). note: if the only signs of decompensation are pretibial or malleolar oedema and the exercise tolerance is still reasonable (absence of dyspnoea) the subject should not be excluded c) cardiac disease potentially resulting in syncope, near syncope or other alterations of mental status
    Descrizione

    comorbidity

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [1,2]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    UMLS CUI [1,3]
    C0009488 (Comorbidity)
    in addition, the following conditions should lead to exclusion: atrial fibrillation without prophylactic treatment to prevent thromboembolic stroke, bradycardia <50 beats/min., atrioventricular block > first degree. d) severe mitral or aortic valvular disease e) hypotension or treatment for hypotension f) systolic blood pressure greater than 170 mmhg or diastolic blood pressure greater than 110 mmhg
    Descrizione

    comorbidity

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0009488 (Comorbidity)
    patients using any agent for the treatment of dementia (approved, experimental, including over the counter agents), including, but not limited to nootropic agents, cholinomimetic agents, choline, oestrogens taken without medical need, chronic nsaids (30 consecutive days), vitamin e more than 30 iu daily, and deprenyl
    Descrizione

    medication

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    conditions that could interfere with the absorption of the compound or with the evaluation of the disease
    Descrizione

    comorbidity

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [1,2]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    UMLS CUI [1,3]
    C0009488 (Comorbidity)

    Similar models

    Eligibility Alzheimer Disease NCT00304629

    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    medication
    Item
    patients must have taken trial medication during the 24-month trial period of gal-int-8 and should be enrolled within 1 month after completion
    boolean
    C0013227 (UMLS CUI [1])
    informed consent
    Item
    patients and their primary caregiver give informed consent for the participation in the trial
    boolean
    C0021430 (UMLS CUI [1])
    health status
    Item
    patients must have remained in good health, as determined by medical history, complete physical examination and laboratory tests
    boolean
    C0018759 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    dementia
    Item
    if a patient developed, during the trial gal-int-8, symptoms of other neurological or psychiatric diseases that might contribute to dementia, the subject cannot be enrolled. this includes subjects developing neurodegenerative disorders such as parkinson's disease, pick's disease or huntington's chorea, or creutzfeldt-jacob disease, and subjects with cognitive impairment resulting from stroke, acute cerebral trauma, hypoxic cerebral damage, infection or primary or metastatic cerebral neoplasia
    boolean
    C0497327 (UMLS CUI [1])
    comorbidity
    Item
    subjects with the following co-existing medical conditions: a) any history of epilepsy or convulsions except for febrile convulsions during childhood b) peptic ulcer: if the ulcer is considered to be still "active", i.e., if treatment for this condition started <3 months ago or if treatment is not successful (symptoms still present), the subject is not eligible. c) clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances
    boolean
    C0009488 (UMLS CUI [1])
    comorbidity
    Item
    patients with current, clinically significant cardiovascular disease that would be expected to limit the subject's ability to complete a 12-month trial. the following would usually be considered clinically significant cardiovascular disease: a) unstable angina
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    comorbidity
    Item
    angina or coronary artery disease that required a change in medication (anti-angina or digitalis) within the last 3 months b) decompensated congestive heart failure i.e. when symptoms occur in a subject on stable medication during rest or light exercise (nyha iii and iv). note: if the only signs of decompensation are pretibial or malleolar oedema and the exercise tolerance is still reasonable (absence of dyspnoea) the subject should not be excluded c) cardiac disease potentially resulting in syncope, near syncope or other alterations of mental status
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    comorbidity
    Item
    in addition, the following conditions should lead to exclusion: atrial fibrillation without prophylactic treatment to prevent thromboembolic stroke, bradycardia <50 beats/min., atrioventricular block > first degree. d) severe mitral or aortic valvular disease e) hypotension or treatment for hypotension f) systolic blood pressure greater than 170 mmhg or diastolic blood pressure greater than 110 mmhg
    boolean
    C0009488 (UMLS CUI [1])
    medication
    Item
    patients using any agent for the treatment of dementia (approved, experimental, including over the counter agents), including, but not limited to nootropic agents, cholinomimetic agents, choline, oestrogens taken without medical need, chronic nsaids (30 consecutive days), vitamin e more than 30 iu daily, and deprenyl
    boolean
    C0013227 (UMLS CUI [1])
    comorbidity
    Item
    conditions that could interfere with the absorption of the compound or with the evaluation of the disease
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])

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